Post-Market Study of the Modular Revision Hip System

Stopped early

Conditions studied: Aseptic Loosening, Osteolysis, Traumatic Fracture, Failed Total Hip Implant

In brief

The purpose of this study is to examine the short term efficacy of the MRH system as well as determine if operating room time is decreased using this simple, two-tray system.

Key facts

Study ID

NCT01464645

Run by

Encore Medical, L.P.

People needed

16

Starts

2012-01-01

Expected to finish

2017-12-01

Last updated by the study team

2018-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be a candidate for revision hip arthroplasty
• Subject must have either poor bone stock or deficiencies of the femoral head, neck or portions of the proximal femur
• Subject's hip joint must be anatomically and functionally suited to receive the hip implant
• Subject must have a body mass index of 40.00 or less (BMI) ≤ 40.00 at time of consent
• Subject must be willing and able to sign the informed consent and follow study procedures
• Subject must be 18 years of age or older (≥ 18) at the time of consent
• Subject must be willing to return for all study visits
• Subject (female) must not be pregnant at time of surgery

You may not qualify if…

• Subject must not be receiving a primary hip replacement
• Subject has a mental condition(s) that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
• Subject has a condition that places excessive demand on the implant including high levels of physical activity (i.e. competitive sports, heavy physical labor)
• Subject has a BMI >40.00
• Subject is skeletally immature
• Subject has osteomyelitis
• Subject has loss of ligamentous structures
• Subject is a prisoner
• Subject is pregnant
• Subject has an active infection or sepsis at time of surgery
• Subject has a history of alcoholism or other addictions (current)
• Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Syringomyelia and Multiple Sclerosis, Charcot joints)
• Subject has known materials sensitivity (to metals)
• Subject has a physical condition that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant
• Subject is unwilling to modify post-operative physical activities
• Subject is younger than 18 years of age (<18) at the time of consent

Where it is running

• Orthopaedic Surgery Specialists — Burbank, California, United States
• Stanford Medical Center Outpatient Clinic — Redwood City, California, United States
• Syracuse Orthopaedic Specialists — Syracuse, New York, United States
• McBride Clinic — Oklahoma City, Oklahoma, United States
• Orthopedic Associates of Pittsburgh, Inc. — Monroeville, Pennsylvania, United States
• Texas Institute for Hip and Knee Surgery — Austin, Texas, United States

Full record on ClinicalTrials.gov

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